# FDA recall D-0335-2024

> **Neptune Resources, LLC** · Class I · drug recall initiated 2024-01-12.

## Product

Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.

## Reason for recall

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0335-2024
- **Recalling firm:** Neptune Resources, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-01-12
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kansas City, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0335-2024

## Citation

> AI Analytics. FDA recall D-0335-2024. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/D-0335-2024. Source: US FDA. Licensed CC0.

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